Saturday, December 10, 2011

Avastin: The Pursuit of Last False Hopes, Extinguished (by Skylanda)

In the past month, the Food and Drug Administration yanked its formal stamp of approval on Avastin– a chemotherapy drug designed to starve tumors of their blood supply – for the advanced stages of breast cancer.Because the drug still carries approval for other indications (especially late-stage colon cancer), patients can still obtain the drug by prescription for off-label use.But because it will lack formal indications for breast cancer, insurers are highly unlikely to continue paying for it.And at an estimated $100,000 per year for sustained use, Avastin is one of the most expensive drugs ever to hit the pharmaceutical market; it is very unlikely that few if any breast cancer patients will be paying for it on their own.

The outcry was immediate and predictable.Breast cancer advocates of some stripes decried the decision as a crime against women’s health – a travesty against hope.The opposition notes that the costs come with desperately little proven benefit, and that the drain on health care resource might go to uses that better suit both breast cancer patients and others who desperately need a slice of the health care pie. (A notably contrary voice in the debate has been the always-stalwart Breast Cancer Action, which applauded the FDA for revoking approval of Avastin, and implored the FDA to “uphold stringent drug approval standards over hasty access without legitimate clinical benefit”).Either way, one can bet the FDA did not tackle this bombshell topic lightly.

On the political side, the enemy of Avastin access is not necessarily the FDA: the FDA did not remove access to Avastin – the functional result of the decision was simply that Avastin will likely not be paid for by insurance because it no longer has an official indication for breast cancer specifically. (Off-label prescribing is allowed for most medications on the market with some rare exceptions – as long as a medications is FDA-approved, doctors can prescribe it for just about any indication, though insurance is less likely to cover expensive medications for unapproved uses.) If the medication were reasonably priced, this would not be an issue; instead, continuous use of the medication costs more than a mortgage on a split-level two-car garage house in most midwestern cities.But there is little outcry against Roche/Genentech, the makers of the drug, for their outrageous price gouging – an implicit collusion between the activist voice and the profit-makers that suspiciously mimics the dynamic between a hostage-taker and the sufferer of an obtuse form of Stockholm syndrome. While breast cancer activism has largely aimed its wrath at the FDA, few outside of Breast Cancer Action have squared off against Roche/Genentech for their rapacious pricing scheme that truly forms the barrier between patients and last-ditch use of the drug.

Avastin is not the first or last drug to land in the middle of such controversy over end-of-life access to drugs with potentially sweeping effects on both disease and remaining normal tissue.The compassionate use movement did not start with antiretroviral drugs – the revolutionary compounds developed in the early 1990s to combat AIDS – but that’s where the move to expedite trials and allow dying adults the right to off-label use outside of regulated trials got a foothold.And perhaps rightly so: during the worst of the AIDS epidemic, the rapid mortality rate far outstripped the ability of formal trials to absorb the number of people who could benefit from them – people who had nothing at all to lose.There is likely no way now to know for sure now, but some AIDS patients probably died faster from unproven and ultimately harmful experimental drugs.Some got the miracles they sought, miracles that are now go by routine names like nevirapine and abacavir, Combivir and Kaletra.This is the legacy that Avastin was born into when it was approved in 2004, and this is the environment that Roche/Genentech banks on when it faces down the FDA with a cadre of its own medico-legal experts backed by an army of breast cancer patients and family girded to fight the battle for a drug that annual nets the pharmaceutical conglomerate some several billion dollars – a sum that will take a large hit in the wake of the FDA’s recent decision.(Bizarrely, one line of this activism invokes a strain of libertarian reasoning that is equally circular as it is paranoid: that Avastin’s revocation by the FDA as a secret victory for ObamaCare socialist cost-control measures – in the same sentence decrying that Medicare will no longer cover the drug without FDA coverage, without ever wondering why Avastin costs so damn much in the first place. Government hands off my Medicare? Indeed.)

So to answer to the real root of whether Avastin should be available to women with stage-four breast cancer – whether the FDA was acting in the best interest of women at large and women with this horrific disease in particular – one also must now ask some tough questions beyond evidence and cost-effectiveness: Is it enough to rely on the internal narrative of the breast cancer patient – the first-person ethnographic voice that drives much of activism in the internet age – when this narrative may conflict openly with medical evidence?Can we rely on patient self-advocacy, when that patient self-advocacy movement had been so intentionally and powerfully tainted by the pharmaceutical manufacturers whose profits rely on the very lucrative and politically powerful business of breast cancer activism?

Every terminally ill person dreams of this age of miracles that AIDS sufferers received in the 1990s – a last-minute Lazarus reprieve that stays the executioner’s bell of their disease.Every pharmaceutical company knows this, and none have shown any moral restraint in invoking this sentiment and this desperation to their advantage, while twisting the knife of a substantial price tag into the backs of sick and dying consumers.As profit-generating entities, this is, after all, their raison d’etre.Pharmaceutical companies are like your distant acquaintance that shows up with supper when you’re sick, only to seduce your husband behind your back: they appear with cheery illusions of comfort.But they are not your friend.

Reasonable solutions are possible, but are unlikely to be invoked.Roche/Genentech could provide the few breast cancer patients who have actually responded to Avastin with supplies of the drug at cost – a true invocation of the phrase “compassionate use” – until this generation of patients fades out; with over a billion dollars a year in profits, this isn’t an unreasonable request.Insurers could also look at these few with some exception in mind.Moreover, research needs to be done (and probably already is) to understand and ultimately predict those exceptional Avastin responders – much as we understand why some breast cancers respond to tamoxifen and Herceptin, and others do not – and tailor chemotherapy regimens specifically for use specifically for people most likely to benefit from Avastin.

Until then, however, the FDA decision stands. Will the decision ultimately save or harm the lives of women with end-stage breast cancer?That remains to be seen.

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